The agreement with Clinlogix is a key step for initiating Tryp's Phase 2a clinical trials
San Diego, California--(Newsfile Corp. - May 10, 2021) - Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (FSE: 8FW) ("Tryp"), a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today a master service agreement with Clinlogix, a Contract Research Organization (CRO), to support Tryp's clinical development of its Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program.
Clinlogix has global experience with providing CRO services for the development of novel pharmaceutical products. The company will collaborate with Tryp and its clinical partners in a number of areas including medical writing, biostatistical analysis, data management, and trial monitoring.
"Clinlogix is pleased to partner with Tryp Therapeutics in support of their next stage in clinical development. We look forward to leveraging our core expertise in clinical research to advance this novel technology," said JeanMarie Markham, Founder & CEO of Clinlogix. "Sharing a common goal to deliver innovative solutions for unmet medical needs, Clinlogix is proud to support Tryp in advancing their novel treatments through the clinical trial process. We look forward to a collaborative and successful partnership!"
Tryp's collaboration with Clinlogix will initially focus on supporting Tryp's upcoming Phase 2a clinical trials for eating disorders and fibromyalgia. These studies are being conducted at leading academic centers, including the University of Florida, with deep expertise in their respective disease areas. Eating disorders such as binge eating and hypothalamic obesity that Tryp is targeting in its Phase 2a clinical study are often poorly addressed by currently available therapies. And Tryp's upcoming Phase 2a clinical trial for fibromyalgia is aimed at providing an additional treatment option for the nearly one-third of patients suffering from the condition that rely on opioids to address their symptoms.
"The proper execution of a clinical study is of paramount importance in order to achieve clinical success; working with the team from Clinlogix provides Tryp with key elements needed for the conduct of a successful clinical study," commented Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp.
About Tryp Therapeutics
Tryp Therapeutics is a pharmaceutical company focused on developing clinical-stage compounds for the treatment diseases with unmet medical needs through accelerated regulatory pathways. Tryp's Psilocybin-For-Neuropsychiatric Disorders, or PFN™, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp's lead PFN™ drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with Dr. Jennifer Miller at the University of Florida.
In addition to its PFN™ Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcomas. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes that TRP-1001 should qualify for orphan status with the FDA.
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About Clinlogix
Founded in 1999, Clinlogix has helped companies conduct complex, next-generation research and find success in new frontiers of health and medicine. By pairing world-class scientific and regulatory leadership with a robust project management approach, the company ensures proper strategic guidance and execution through the entire program. From concept to commercialization, we leverage the expertise of a thoroughly vetted global network of scientific advisors and thought leaders to ensure excellence in every project. Clinlogix is headquartered in Lower Gwynedd, Pennsylvania, and has offices in Japan, Germany, and Colombia to support global product development programs.
Forward-Looking Information
Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", "is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the "Risk Factors" section of Tryp's final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
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